Aneurysm Treatment Device And Method Of Use

ABSTRACT

An apparatus for treating vascular aneurysms includes an occlusive support device comprised of one or more support members. The occlusive device has, an end cap member and an anchoring member. The end cap member is comprised of at least one of one or more of the support members. The end cap member has openings and the end cap member comprises a reactive material that is configured to hydrate upon delivery of the device and to reduce the size of said openings. The device is configured so that the occlusive members can be positioned in the blood vessel proximate the neck of a vascular aneurysm, the reactive material hydrates and increases the resistance to blood flow into the aneurysm, and the anchoring member anchors the device in the blood vessel without occluding flow through the blood vessel.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 10/763,975, entitled “Aneurysm Treatment Device andMethod of Use,” filed on Jan. 22, 2004, the entire contents of which arehereby incorporated in its entirety. The present application is also acontinuation-in-part of U.S. patent application Ser. No. 09/909,715,entitled “Aneurysm Closure Device and Method of Use,” filed on Jul. 20,2001, the entire contents of which are hereby incorporated by referencein its entirety. The entire contents of U.S. patent application Ser. No.09/804,935, entitled “Hydrogels That Undergo Volumetric Expansion InResponse To Changes In Their Environment And Their Methods OfManufacture And Use,” filed on Mar. 31, 2001, naming Gregory M. Cruiseand Michael J. Constant as co-inventors, is hereby incorporated in itsentirety by this reference.

BACKGROUND

Generally, the mammalian circulatory system is comprised of a heart,which acts as a pump, and a system of blood vessels which transport theblood to various points in the body. Due to the force exerted by theflowing blood on the blood vessel the blood vessels may develop avariety of vascular disabilities or dysfunctions. One common vasculardysfunction known as an aneurysm results from the abnormal widening ofthe blood vessel. Typically, vascular aneurysms are formed as a resultof the weakening of the wall of a blood vessel and subsequent ballooningof the vessel wall. As shown in FIG. 1, the aneurysm 10 often comprisesa narrow neck portion 12 which is in communication with the blood vessel14 and a dome portion 16 in communication with the neck portion 12. Asshown in FIG. 1 the neck portion 12 and the dome portion 16 form acavity 18. Aneurysms have been known to form in a plurality of locationthough the body, including, for example, the brain, the abdomen, andthroughout the circulatory system.

In response, several surgical techniques for treating aneurysms havebeen developed. Initially, an aneurysmectomy was required to repair thedysfunctional tissue. The aneurysmectomy procedure requires the surgeonto gain access to the aneurysm, excise the aneurysm, and replace thevoid with a prosthetic graft. Because this is a major surgicalundertaking, the mortality rate of the procedure is relatively high.Commonly, the aneurysmectomy procedure is unavailable to patients withsevere coronary or cerebral arteriosclerosis, severe restrictivepulmonary disease, and significant renal disease or other complicatingfactors. An alternate method of treating cerebral aneurysms called‘microsurgical clipping’ requires the placement of a metallic clipacross the neck of the aneurysm, thereby excluding the aneurysm from theblood flow.

In response to the shortcomings of the aneurysmectomy and themicrosurgical clipping procedures, less invasive methods of treatmenthave been developed. Commonly, these procedures require the formation ofan artificial vaso-occlusion, which is obtained by implanting a numberof devices or suitable materials into the cavity 18 of the aneurysm,thereby resulting in a decrease in the flow of blood into the aneurysm.The reduced flow results in hemostasis and the formation of a clot.Generally, this procedure requires the surgeon to advance amicro-catheter to a location inside the aneurysm and deposit abiologically-compatible vaso-occlusive material or device therein.Typical vaso-occlusive devices and materials include platinummicro-coils, hog hair, microfibrillar collagen, various polymericagents, material suspensions, and other space filling materials.

FIG. 2 shows an aneurysm 10 formed on a blood vessel 14, the aneurysm 10having a vaso-occlusive device 20 positioned within the aneurysm dome18. A disadvantage of filling an aneurysm with devices is that thevaso-occlusive mass may impinge on nerves or other biologicalstructures, thereby resulting in adverse biological symptoms. Forexample, the impingement of the vaso-occlusive device 20 on structuresor nerves within the brain, commonly known as ‘mass effect’, may resultin adverse neurological symptoms. Another problem associated withvaso-occlusive devices is maintaining the device within the aneurysm.Blood flow through an otherwise functional blood vessel may becompromised should the device migrate from the aneurysm during orfollowing implantation, thereby possibly resulting in a vascularembolism. Yet another problem associated with certain vaso-occlusivedevices, such as coils, is that the coils may migrate out of aneurysmshaving wide necks into the parent vessel. Thus, only aneurysms havingcertain dome to neck ratios can be treated in this fashion.

An alternate method of repairing an aneurysm has been developed whichrequires the implantation of a mechanical support device within theblood vessel near the neck portion of the aneurysm. Generally, thesemechanical support devices, commonly referred to as “stents”, comprisedeployable mechanical support structures capable of delivery to a situswithin the blood vessel through catheters. In addition to providingmechanical support to the dysfunctional vessel wall, the stent mayinclude a mechanical structure which seeks to restrict the blood flowthough the portion of the blood vessel proximate the aneurysm, therebyreducing or eliminating the aneurysm. The stent may also be useful inpreventing coils from migrating out of the aneurysm. Exemplarymechanical structures capable of restricting blood flow to an aneurysminclude meshes or fenestrated structures which are positioned near ananeurysm 10 and restrict the flow of blood thereto.

FIG. 3 shows a stent 22 positioned in a blood vessel 14 proximal to ananeurysm 10. While a stent may provide adequate mechanical support tothe blood vessel, these devices have demonstrated limited effectivenessin limiting blood flow to the aneurysm. As such, the aneurysm typicallyremains intact and may increase in size. In response, stents may becovered with various coatings designed to limit blood flow to theaneurysm. These coatings typically include biologically compatiblepolymers, films, and fabrics. However, the application of these coatingsto the stents increases the cross-sectional diameter of the device,thereby resulting in a high profile stent-graft. As a result, the bloodflow through the blood vessel is reduced by the presence of a highprofile stent-graft. In addition, device profile is a significantproblem for the treatment of cerebral aneurysms due to the small size ofthe cerebral blood vessels, therefore requiring the device to bedeliverable to the aneurysm through a micro-catheter. As such, highprofile stent-grafts are typically not used in the treatment of cerebralaneurysms.

There are additional limitations in the use of conventional stents totreat cerebral aneurysms. Since stents have a cylindrical shape, it isless useful for treating an aneurysm that is formed at a bifurcation ofan artery or in arteries with complex geometries. Also, self-expandingstents can be difficult to deliver because, when collapsed, they willexert a radial force on the delivery sheath that is proportional to itslength. The user must overcome this radial force to deliver the stent.As the delivery sheath is retracted against this force, energy is storedin the delivery system and released as the stent is deployed, causingconsiderable movement in the system during deployment. This issue isusually addressed by utilizing a stent that is longer than the aneurysmneck so that accuracy of delivery is less crucial. However, this alsotends to increase the radial force holding the stent in the deliverysystem which only exacerbates the problem of stored energy, thuscreating a viscous cycle. Balloon expandable stents can mitigate thisproblem, but the balloon makes the device stiffer and more difficult tonavigate tortuous cerebral anatomy.

Thus, there is presently an ongoing need for a device and method foreffectively treating aneurysms without significantly affecting bloodflow through the blood vessel.

There is also an ongoing need for a device that can be used inconjunction with or in lieu of coils that can occlude an aneurysmwithout adversely affecting blood flow through the vessel.

SUMMARY

The aneurysm treatment devices of the present application effectivelyocclude or inhibits blood flow to an aneurysm without substantiallyimpairing blood flow through the blood vessel. In addition, the aneurysmtreatment devices of the present application are capable of beingapplied to a variety of aneurysms formed on blood vessels throughout thebody.

In one embodiment, the aneurysm treatment device of the presentinvention comprises at least one support member and reactive materialselectively applied to the support member. The at least one supportmember, which has at least a first surface capable of receiving thereactive material, provides a substrate for receiving the reactivematerial. Alternatively, the at least one support member may alsoprovide support to weakened vascular tissue. The reactive material has anon-reacted state and a reacted state. In a reacted stated the reactivematerial, as selectively applied to the at least one support member, iscapable of increasing the resistance to the flow of blood to theaneurysm. In an alternate embodiment, the at least one support membermay be manufactured from or otherwise incorporate reactive materialtherein. The device is preferably controllably released from an elongatedelivery apparatus. The release mechanism may be any of thevaso-occlusive device and stent detachment means known in the artincluding but not limited to mechanical, electrolytic,electro-mechanical, thermal, hydraulic, and shape-memory means.

In an alternate embodiment, the present invention is directed to avascular patch comprising a radially and axially flexible patch bodyformed by a plurality of interlocking support members. The interlockingsupport members, which are capable of supporting vascular tissue, form aplurality of fenestrations. A reactive material capable of increasingthe resistance to the flow of blood to an aneurysm is selectivelyapplied to, woven into, integral to, or otherwise incorporated into theinterlocking support member. For example, the interlocking member may bemanufactured from fibrous or formed reactive material

In yet another embodiment, the present invention is directed to a coiledbridge device comprising radially and axially flexible resilientsinusoidal body member which defines a plurality of openings. Thesinusoidal body member has a first radius of curvature R and a secondradius of curvature R′, wherein R′ is larger than R. The sinusoidal bodymember is formed by at least one support member and has a reactivematerial capable of increasing the resistance to the flow of blood to ananeurysm, selectively applied thereto.

In another embodiment, the present invention is directed to a helicalstent having a radially and axially flexible cylindrical body memberpositioned between a first end and a second end. The cylindrical bodymember, which is formed by at least one support member capable ofsupporting vascular tissue, defines an internal lumen which is incommunication with the first and second ends. A reactive materialcapable of increasing the resistance to the flow of blood to an aneurysmis selectively applied to the at least one support member.

In yet another embodiment, the present invention is directed to ahelical stent having a radially and axially flexible cylindrical bodymember positioned between a first end and a second end. The cylindricalbody member, which is formed by at least one support member capable ofsupporting vascular tissue, defines an internal lumen which is incommunication with the first and second ends. A reactive materialcapable of increasing the resistance to the flow of blood to an aneurysmis selectively applied to the at least one support member.

In another embodiment, the present invention is directed to areticulated expandable stent comprising radially and axially flexiblecylindrical body member positioned between a first end and a second end.The cylindrical body member, which is formed by at least one supportmember capable of supporting vascular tissue, defines an internal lumenwhich is in communication with the first and second ends. A reactivematerial capable of increasing the resistance to the flow of blood to ananeurysm is selectively applied to the at least one support member.

In still another embodiment, the present invention is directed to abifurcated vascular support device comprising a bifurcated body memberpositioned between a first end, a second end, and a third end. Thebifurcated body member further defines an internal lumen whichcommunicates with the first, second, and third ends. The bifurcated bodymember is formed by at least one support member capable of supportingvascular tissue. A reactive material capable of increasing theresistance to the flow of blood to an aneurysm is selectively applied tothe at least one support member.

In another embodiment, the present invention is directed to anintra-aneurysmal bridge device comprising a flexible bridge body incommunication with at least two engagement members. The at least twoengagement members cooperatively form a joint. A reactive materialcapable of increasing the resistance to the flow of blood to an aneurysmis selectively applied to the at least two engagement members.

The present invention also discloses a novel method of treating avascular aneurysm. More particularly, the novel method of treatingvascular aneurysms comprises the steps of providing a device fortreating vascular aneurysms having a reactive material applied thereto,delivering the device to a vascular aneurysm, supporting the tissue nearthe aneurysm with the device, and allowing the reactive material toreact thereby permitting the flow of blood through the blood vesselwhile increasing the resistance to the flow of blood to the aneurysm

In yet another embodiment, the present application discloses anapparatus for treating vascular aneurysms and includes a radiallyexpandable structure formed from at least one support member anddefining a plurality of openings, and at least one reactive materialselectively applied to a portion of the at least one support member. Thereactive material is configured to assume a reacted state whichincreases the resistance to the flow of blood to an aneurysm.

In another embodiment, the present application discloses an apparatusfor treating aneurysms and includes at least one support member definingan expandable support body, at least one reactive material selectivelyapplied to at least one support member and having a non-reacted stateand a reacted state. The support member has a diameter D in anon-reacted state and a diameter D′ in a reacted state, wherein diameterD′ is larger than diameter D.

In another embodiment, the present application is directed to anapparatus for treating vascular aneurysms and includes an occlusivesupport defined by one or more support members and having a first endand a second end and a lumen formed therein, one or more fenestrationsformed on the occlusive support and configured to permit blood to flowtherethrough, an end cap secured to the second end and configured torestrict the flow of blood therethrough. The end cap may be configuredto have a relatively short extension along the longitudinal axis of thedevice. In one embodiment the extension of the end cap is less than twotimes the end cap diameter. In another embodiment the extension of theend cap along the longitudinal axis of the device is less than the endcap diameter.

In another embodiment, the present application is directed to anapparatus for treating vascular aneurysm and includes an occlusivesupport device having a first end portion and a second end portion, amesh member at said first end portion of the occlusive support device,an anchoring member at the said second end portion, and a plurality ofelongated members connecting the mesh member to the anchoring member.

The present application further discloses a method of treating avascular aneurysm and includes providing a device having a reactivematerial selectively applied to at least one support member, deliveringthe device to a position in a blood vessel proximate a vascularaneurysm, expanding the device to approximately a diameter of a bloodvessel, and activating the reactive material disposed on the device toreduce the flow of blood into the aneurysm.

In another embodiment, the present application discloses a method oftreating a vascular aneurysm and includes providing a device having atleast one support member and an end cap secured to the support member,delivering the device to a position in a blood vessel proximate avascular aneurysm, expanding the device to approximately the diameter ofthe blood vessel, and reducing a flow of blood to the aneurysm with theend cap while permitting blood flow through the blood vessel.

In another embodiment, the present application discloses a method oftreating a vascular aneurysm and includes providing a device having atleast one support member and an end cap secured to the support member,delivering the device to a position in a blood vessel proximate avascular aneurysm, expanding the device to approximately the diameter ofthe blood vessel, delivering a catheter through the blood vessel to aposition proximate to the vascular aneurysm, inserting a space occupyingmaterial into the aneurysm, and maintaining the space occupying materialwithin the aneurysm with the end cap to reduce the flow of blood intothe aneurysm.

In another embodiment, the present application discloses a method oftreating a vascular aneurysm and includes providing a device having atleast one support member and an end cap secured to the support member,the end cap having a reactive material disposed thereon, delivering thedevice to a position in the blood vessel proximate a vascular aneurysm,expanding the device to approximately a diameter of a blood vessel,delivering a catheter through the blood vessel to a position proximateto the vascular aneurysm, inserting a space occupying material into theaneurysm, and activating the reactive material to maintain the spaceoccupying material within the aneurysm with the end cap to reduce theflow of blood into the aneurysm.

In yet another embodiment, the present application discloses a method oftreating a vascular aneurysm and includes providing a device having anocclusive member at a first end portion and an anchoring member at asecond end portion, and a plurality of elongated members connecting theocclusive member to the anchoring member, positioning the device in theblood vessel so that the occlusive member is proximate the neck of avascular aneurysm to reduce the flow of blood into the aneurysm,deploying the elongated members and then the deploying anchoring memberin the blood vessel so that that anchoring member anchors the device inthe blood vessel without occluding flow through the blood vessel.

Other objects and further features of the aneurysm treatment device ofthe present application will become apparent from the following detaileddescription when read in conjunction with the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The aneurysm treatment device of the present application will beexplained in more detail by way of the accompanying drawings, wherein:

FIG. 1 shows a cross-sectional view of a blood vessel having a vascularaneurysm formed on its wall;

FIG. 2 shows a cross-sectional view of a prior art method of treatingvascular aneurysm requiring the deposition of space-filling materialwithin the vascular aneurysm;

FIG. 3 shows a cross-sectional view of an alternate prior art method oftreating vascular aneurysm wherein a mechanical stent is positioned nearan aneurysm;

FIG. 4 shows a sectional view of a support member of an aneurysmtreatment device having non-reacted reactive material disposed thereon;

FIG. 5 a shows a sectional view of a support member of an aneurysmtreatment device having reacted reactive material disposed thereon;

FIG. 5 b shows a perspective view of an embodiment of an aneurysmtreatment device comprising a structure having reactive materialinterwoven therein in a non-reacted state;

FIG. 5 c shows a perspective view of an embodiment of an aneurysmtreatment device comprising a structure having reactive materialinterwoven therein in a reacted state;

FIG. 5 d shows a perspective view of an embodiment of an aneurysmtreatment device having a reactive material strand wrapped around asupport member;

FIG. 5 e shows a cross-sectional view of an embodiment of an aneurysmtreatment device having a reactive material strand wrapped around asupport member;

FIG. 5 f shows a sectional view of an embodiment of an aneurysmtreatment device having a support member with a variable tangentialwidth and a reactive material strand applied thereto;

FIG. 5 g shows another sectional view of an embodiment of an aneurysmtreatment device having a support member with a variable tangentialwidth and a reactive material strand applied thereto;

FIG. 6 shows a perspective view of an embodiment of an aneurysmtreatment device comprising a vascular patch device useful inrestricting the flow of blood to a vascular aneurysm;

FIG. 7 shows another perspective view of an embodiment of an aneurysmtreatment device comprising a vascular patch device useful inrestricting the flow of blood to a vascular aneurysm;

FIG. 8 shows a perspective view of an embodiment of an aneurysmtreatment device positioned within a blood vessel proximate a vascularaneurysm;

FIG. 9 shows a cross-sectional view of an embodiment of an aneurysmtreatment device positioned within a blood vessel proximate a vascularaneurysm;

FIG. 10 shows a perspective view of an embodiment of an aneurysmtreatment device comprising a coiled bridge device useful in restrictingthe flow of blood to a vascular aneurysm;

FIG. 11 shows a perspective view of another embodiment of an aneurysmtreatment device comprising a coiled bridge device useful in restrictingthe flow of blood to a vascular aneurysm;

FIG. 12 shows a cross-sectional view of an embodiment of the aneurysmtreatment device of FIG. 11 positioned within a blood vessel proximate avascular aneurysm;

FIG. 13 shows a perspective view of an embodiment of an aneurysmtreatment device comprising a helical stent device useful in restrictingthe flow of blood to a vascular aneurysm;

FIG. 14 shows a perspective view of another embodiment of an aneurysmtreatment device comprising a helical stent device useful in restrictingthe flow of blood to a vascular aneurysm;

FIG. 15 shows a cross-sectional view of the embodiment of the aneurysmtreatment device shown in FIG. 14 positioned within a blood vesselproximate a vascular aneurysm;

FIG. 16 shows a perspective view of another embodiment of an aneurysmtreatment device comprising a reticulated stent device useful inrestricting the flow of blood to a vascular aneurysm;

FIG. 17 shows a perspective view of another embodiment of thereticulated stent device useful in restricting the flow of blood to avascular aneurysm;

FIG. 18 shows a cross-sectional view of an embodiment of an aneurysmtreatment device comprising a reticulated support device positionedwithin a blood vessel proximate a vascular aneurysm;

FIG. 19 shows a cross-sectional view of an embodiment of an aneurysmtreatment device comprising a bifurcated stent device positioned withina blood vessel proximate to a vascular aneurysm;

FIG. 20 shows a sectional view of an embodiment of an aneurysm treatmentdevice comprising an occlusive support positioned within a blood vesselproximate to a vascular aneurysm;

FIG. 21 shows a sectional view of an embodiment of an aneurysm treatmentdevice having a catheter delivering a space occupying material to avascular aneurysm through an occlusive support positioned within ablood;

FIG. 22 shows a perspective view of an embodiment of an aneurysmtreatment device having an occlusive member at a first end portion andan anchoring member at a second end portion, and a plurality ofelongated members connecting the occlusive member to the anchoringmember;

FIG. 23 shows a sectional view of the embodiment of FIG. 22 positionedwithin a blood vessel proximate to a vascular aneurysm;

FIG. 24 shows a partial longitudinal sectional view of a solid, elongatedevice which has a reactive material disposed thereon in accordance withthe present invention;

FIGS. 25 a-25 d show, in step by step fashion, a method formanufacturing a device having a reactive material disposed thereon;

FIG. 26 shows a perspective view of an embodiment of an aneurysmtreatment device comprising an intra-aneurysmal bridge device ananeurysm treatment device useful in restricting the flow of blood to avascular aneurysm;

FIG. 27 shows a sectional view of an embodiment of the aneurysmtreatment device shown in FIG. 26 positioned within a vascular aneurysm;and

FIG. 28 shows a perspective view of an embodiment of an aneurysmtreatment device positioned on an expandable balloon micro-catheterwithin a blood vessel.

DETAILED DESCRIPTION

Disclosed herein is a detailed description of various illustratedembodiments of the invention. This description is not to be taken in alimiting sense, but is made merely for the purpose of illustrating thegeneral principles of the invention. The section titles and overallorganization of the present detailed description are for the purpose ofconvenience only and are not intended to limit the present invention.

The aneurysm treatment devices of the present application are generallyused to restrict the ability of blood flowing through a blood vesselfrom entering an aneurysm formed thereon or to otherwise limit theamount of blood within an aneurysm. The devices disclosed herein may beapplied to a blood vessel in a variety of ways, including, withoutlimitation, conventional surgical techniques and minimally invasivesurgical techniques utilizing catheters of various sizes, ballooncatheters, micro-catheters, and other ways generally known in the art ofminimally invasive surgery. The aneurysm treatment devices disclosedherein may be used to repair a variety of aneurysms at various locationsthroughout the body. For example, in one embodiment these devices may beused in procedures to repair or otherwise treat cerebrovascularaneurysms.

The devices and methods of the present application have particularcompatibility with the materials and methods of manufacture and usedisclosed in co-pending U.S. patent application Ser. No. 09/804,935filed on Mar. 13, 2001, entitled “Hydrogels That Undergo VolumetricExpansion In Response To Changes In Their Environment And Their MethodsOf Manufacture And Use,” and co-pending U.S. patent application Ser. No.09/909,715 filed on Jul. 20, 2001, entitled “Aneurysm Treatment Devicesand Methods of Use,” each of which has been assigned to the assignee ofthe present application and which are incorporated by reference as ifset forth herein in their entirety. Those skilled in the art willappreciate that the present invention may be manufactured with one ormore of a variety of alternate reactive materials applied thereto,including, for example, collagen-polymer conjugate materials,photopolymerizable biodegradable materials, and other biodegradablecross-linked hydrogels known in the art.

Aneurysms form as a result of outward pressure applied to a diseased ordamaged blood vessel wall by blood flowing within the vessel, therebyresulting in a weakened section of tissue ballooning outwardly from ablood vessel. FIG. 1 shows an aneurysm 10 comprising a neck portion 12in communication with a blood vessel 14 and having a dome portion 16defining aneurysm cavity 18. Those skilled in the art will appreciateFIG. 1 illustrates an exemplary vascular aneurysm and is not intended tolimit the scope or intent of the present invention.

One method of treating an aneurysm requires the formation of an embolismproximate to or within the aneurysm, thereby restricting or deprivingthe aneurysm of blood flow and reducing the likelihood the aneurysm willrupture. FIGS. 2 and 3 show prior art devices used to repair aneurysmsby artificially creating embolisms within or proximate to the aneurysm.In FIGS. 2 and 3 the reference numerals 10, 12, 14, 16, and 18 haveanalogous meanings to the reference numerals identifying the features ofFIG. 1. FIG. 2 shows an aneurysm 10 in communication with a blood vessel14. As shown, a vaso-occlusive device 20 is positioned within theaneurysm cavity 18. Typically, a micro-catheter or other device is usedto inject or otherwise insert the vaso-occlusive device 20 into theaneurysm cavity 18, thereby decreasing the volume of the aneurysmcapable of receiving blood from the blood vessel 14. FIG. 3 showsanother device useful in treating aneurysms. As shown in FIG. 3, a stent22 is positioned within a blood vessel 14 proximate to an aneurysm 10. Astent 22 is a mechanical scaffold used to provide support to otherwiseincompetent or weakened tissue or to or maintain the patency of anarrowed or occluded blood vessel.

The present application discloses various embodiments of devices usefulfor the embolization or isolation of aneurysms. More particularly, thepresent application discloses various structures capable of implantationwithin an aneurysm or configured to be inserted into a blood vesselproximate to an aneurysm. Exemplary aneurysm treatment devices disclosedherein include, without limitation, neck bridges, vascular patches,stents, and intra-aneurysmal implants. In one embodiment, an aneurysmtreatment device may include a series of interlocking or otherwiseconnected support members forming a predetermined shape. In an alternateembodiment, the aneurysm treatment device comprises an implant bodywhich may be partially or completely inserted into an aneurysm formed ona blood vessel. The implant body may form a predetermined shape or, inthe alternative, may form a random shape.

FIGS. 4 and 5 a show cross sectional views of a portion of a supportmember 24 as used in the formation of a number of embodiments of theaneurysm treatment device of the present application before andfollowing implantation. As shown in FIG. 4, the support member 24 maycomprise a device substrate 26 having a reactive coating or covering orreactive material 28 applied to the exterior portion thereof prior toimplantation. Once the material 28 has reacted it decreases the porosityof the support member 24 and thereby reduces the flow of blood throughthe walls of the device. The support member 24 having a non-reactedreactive coating or covering thereon has a first diameter of D. FIG. 5 ashows reactive material 28 disposed on the support member 24 in areacted state, wherein the reactive material 28 has expanded outwardlyfrom the device substrate 26 in a preferential direction. As shown, in areacted state the support member 24 assumes a second diameter of D′,wherein the second diameter D′ is larger than the first diameter D. Thereactive material 28 may expand to increase the diameter of the supportmember 24 by between 10% and 200%. For example, in one embodiment thesecond diameter D′ is about 20% larger than the first diameter D. Inanother embodiment the second diameter D′ is at least about 25% largerthan the first diameter D. Further, the reactive material 28 can expandin its reactive state to fill at least about 20% of the previously openarea between adjacent support members 24. In the illustrated embodiment,the reactive material 28 has expanded more along the horizontal axisthan the vertical axis. This permits the reactive material to inhibitflow outwardly through the device in the radial direction whileminimizing its impact on longitudinal flow through the device and alsominimizing the reactive material's impact on the overall profile of thedevice.

FIGS. 5 b and 5 c show an alternate embodiment of an aneurysm treatmentdevice comprising a reactive material strand or wrap positioned on asupport member 24. A number of support members 24 are interwoven therebyforming an interwoven structure 27. Reactive material or strands 28 mayapplied to a support member 24 or positioned within the interwovenstructure 27 in a radial, axial, or radially and axial orientation. Forexample, a support member 24 may be wrapped with a reactive materialstrand 28. In an alternate embodiment, a reactive strand 28 may bedisposed within the interwoven structure 27. Optionally, a reactivestrand 28 may be interwoven within the structure 27. FIG. 5 b shows anembodiment of the aneurysm treatment device with the reactive material28 in a non-reacted state. As shown in FIG. 5 b, the orifices 29 formedby the reactive material strand 28 and surrounding support members 24have a first area of A. FIG. 5 c shows the material strands 28 of theaneurysm treatment device in a reacted state wherein the orifices 29formed by the reactive material strand 28 and surrounding supportmembers 24 have a second area of A′. As shown, the second area A′ of theorifices 29 in a reacted state is less than the first area A of theorifices in a non-reacted state, thereby limiting or inhibiting the flowtherethrough. For example, the second area A′ of the orifices 29 in areacted state is at least about 20% less then the first area A of theorifices in a non-reacted state.

Referring again to FIGS. 4 and 5 a, the reactive material 28 may havesecondary operations performed on it, after it has been applied, toremove material in certain areas. In one embodiment, the reactivematerial may applied to the support members 24 in a substantiallyuniform thickness and then machined to remove some of the material fromthe inner and outer surfaces of the device to reduce the thickness ofthe reactive material 28 in those areas thereby reducing the overallradial thickness or profile of the device.

Additionally, the support members 24 of the various embodiments of theaneurysm treatment device may be manufactured from a plurality ofbiologically-compatible materials. For example, in one embodiment atleast one support member 24 is manufactured from materials including,without limitation, platinum, gold, tantalum, titanium, stainless steel,tungsten, Nitinol, shape memory alloys, formed reactive material, orother suitable material. Optionally, at least one support member 24 maybe manufactured from a variety of biologically-compatible polymermaterials, including, but not limited to, polyurethane, polyvinylalcohol, polyester, polytetrafluoroethylene, silicone, acrylic, orsimilar polymeric materials. At least one support member 24 mayincorporate radio-opaque or echogenic materials or agents, therebyenabling the surgeon to precisely position the device within ananeurysm, blood vessel, or other hollow organ.

At least one support member 24 used in forming an aneurysm treatmentdevice includes at least one reactive material 28 applied thereto. Thereactive material 28 may be applied in a variety of ways known in theart. For example, one or more support members 24 may be coated with areactive material 28. In an alternate embodiment, one or more supportmembers 24 may have a reactive material 28 selectively applied thereto.For example, a reactive material 28 may be wrapped around or adhesivelybonded to a portion of a support member 24. FIGS. 5 d-5 e show variousembodiments of an aneurysm treatment device having a reactive fiberstrand 28 applied thereto. As shown, the aneurysm treatment devicecomprises a support member 24 defining an internal passage 25. A portionof the support member 24 includes a reactive fiber stand 28 encircling aportion of the support member 24. In one embodiment, the reactive fiberstrand may be adhesively coupled to the support member 24. For example,a fiber substrate having an adhesive applied to one surface and areactive material 28 applied thereto may be positioned on or selectivelyapplied to one or more support members 24.

The support member 24 receiving the reactive material strand 28 may havea constant or variable diameter or tangential width. For example, FIGS.5 f and 5 g show an embodiment of a support member 24′ having a variabletangential width. Support member 24′ may be fabricated, for example,with a reduced diameter or tangential width, so that placement of thereactive material strand 28 around the support member 24′ results insupport member 24′ having a tangential thickness that is substantiallythe same as the other support members 24′. As such, the diameter of thesupport member 24′ having the reactive material wrap 28 applied theretois approximately equal to the diameter of surrounding support members24. As a result, the diameter of the aneurysm treatment device in anon-reacted state remains substantially constant. Additionally, thedensity of the device is not substantially greater in the region wherethe reactive material strand 28 is applied until after expansion occurs.In one embodiment, the reactive material wrap 28 is closely wound aboutthe support member 24′ so that when expansion occurs, it maximizes thechange in diameter, thereby obstructing more flow between supportmembers. In an alternate embodiment, the reactive material wrap 28 maybe intermittently applied to the support member 24′. Further, there maybe gaps between the reactive material wrap 28 windings. The reactivematerial strand 28 may have a diameter that is between 10% and 200% ofthe largest thickness of the support member 24. The reactive materialwrap 28 may be attached to itself, to the support member 24, or bothusing attachment means well known in the art of biomaterials assembly,such as heat, adhesives, and the like. The reactive material wrap may bemade from any of the reactive materials disclosed herein and may alsoinclude a core member of non-expansible material.

Optionally, at least one support member 24 and\or the reactive material28 applied to the support member 24 may include one or more therapeuticagents applied thereto. Exemplary therapeutic agents include, forexample, embolizing factors, anti-embolizing factors, andanti-restenotic compounds. For example, the reactive material 28 appliedto one or more support members 24 may be chemically doped or impregnatedwith a drug, compound, bioactive agent and/or cellular material topromote endothelial cellular adhesion. A portion of the support member24 or a portion of the reactive material 28 may be coated or modified toincorporate elements that promote the adhesion of beneficial cells orgrowth factors. An exemplary material is described in US PatentApplication Publication Number 2002/0049495 to Kutryk et al. which isincorporated in its entirety by this reference. In an alternateembodiment, the reactive material 28 applied to one or more supportmembers 24 may be chemically doped or impregnated with a drug orcompound to promote tissue growth or impart other therapeutic benefitabout the support member 24.

The reactive material 28 may be fabricated from a plurality of materialscapable of expanding or volumetrically changing over time within thepresence of blood or other fluid. For example, the Applicant'sco-pending U.S. patent application Ser. No. 09/804,935 filed on Mar. 13,2001 entitled “Hydrogels That Undergo Volumetric Expansion In ResponseTo Changes In Their Environment And Their Methods Of Manufacture AndUse” discloses a hydrogel useful as a reactive coating or covering orreactive material 28 for treating aneurysms. The above-referencedhydrogel comprises 1.25 g (0.021 moles) acrylamide, 0.87 g (0.009 moles)sodium acrylate, 0.005 g (0.00003 moles) N,N-methylenebisacrylamide,7.95 g water, and 4.5 g sodium chloride (<10 micron particle size) addedto an amber jar. The initiators, 53 microliters ofN,N,N′,N-tetramethylethylenediamine and 65 microliters of 20% w/wammonium persulfate in water, are added and the solution is aspiratedinto a 3-cc syringe. The solution is then injected into 0.025″ ID tubingand allowed to polymerize for 2 hours. The tubing is cut into 2-inchsections and dried in a vacuum oven. The dried hydrogel is washed 3times in distilled water for 10-12 hours, 2 hours, and two hours,respectively, to remove porosigen, any unreacted monomer and anyunincorporated monomers. The hydrogel may then be cut into sections ofapproximately 0.100 inch length called “pellets” and skewered with aplatinum coil/wire assembly. In the alternative, the hydrogel may bedrawn or formed into fibrous strands or portions of similar size anddimension as the support members 24. These pellets or strands are thenhydrated in alcohol and dried under vacuum at approximately 55 C. forabout 2 hours.

Thereafter, the dried pellets or strands are then placed in 50%hydrochloric acid/50% water and incubated for about 70 hours at 37 C.After the incubation, the excess hydrochloric acid solution is rinsedoff of the pellets or strands with consecutive rinses of a) 70%isopropyl alcohol: 30% water for about 5 minutes, b) 100% isopropylalcohol for about 15 minutes, c) 100% isopropyl for about 15 minutes andd) 100% isopropyl alcohol for about 15 minutes. The hydrogel pellets orstrands are then dried under vacuum at 55 C. for at least 2 hours. Priorto or following the complete drying process, the pellets or strands maybe selectively applied to the at least one support member 24 as desiredin a plurality of ways. In one embodiment the reactive material 28 isapplied to the entire surface of a support member 24. For example, thereactive material 28 may be maintained in a liquid form and a supportmember 24 may be submerged therein, thereby coating or covering theentire surface of the support member 24. In an alternate embodiment, thereactive material 28 is selectively applied to a portion of the supportmember 24. For example, the reactive material 28 may be selectivelyapplied to the portion of a support member 24 which will engage a wallof a blood vessel. Optionally, a strand of the reactive material 28 maybe wound about or around a support member 24. In another embodiment, thereactive material 28 may be applied to a substrate having a biologicallycompatible adhesive applied thereto. Thereafter, the substrate may beadhered to a support member 24 thereby applying the reactive material 28thereto.

Once implanted in vivo, the reactive material 28 of the presentembodiment becomes fully swollen within approximately one hour atphysiological pH (about 7.4). For example, in one embodiment thereactive material 28 positioned on the support member 24 from a diameterof about 0.026 inch to a diameter of about 0.035 inch. As such, thecross sectional diameter of the support member 24 having reactedreactive material 28 thereon is about 25% larger than the crosssectional diameter of the support member 24 having non-reacted reactivematerial 28 thereon. Alternatively, the strands of reactive material 28may be woven or integrated into the support structure. Optionally, thesupport structure 24 may be manufactured from a reactive material 28without a substrate 26. (See FIG. 4)

FIGS. 6-9 show an embodiment of an aneurysm treatment device useful inisolating an aneurysm from a blood vessel. As shown in FIG. 6, theaneurysm treatment device comprises a vascular patch device 30 having abody member 32 formed by a plurality of interwoven or otherwise joinedsupport members 24 axially displaced in relation to each other andcapable of supporting weakened vascular tissue. The interwoven supportmembers 24 form a plurality of fenestrations 34. In FIGS. 6-8, areactive material 35 is selectively applied to the interwoven supportmembers 24. As illustrated, the present embodiment permits the isolationand embolization of an aneurysm formed on a blood vessel withoutsubstantially occluding blood flow therethrough. As shown in FIG. 7, thevascular patch device 30 is formed by the plurality of support members24 and may have an arcuate profile 36. In one embodiment, the arcuateprofile 36 may be selected to approximate the radius of curvature of thereceiving blood vessel, thereby further limiting blood vessel occlusionfollowing implantation. The vascular patch device 30 may be manufacturedin a variety of sizes, lengths, and radiuses. For example, the vascularpatch device 30 may approximate 270 degrees of the receiving bloodvessel, thereby using mechanical force to secure the device within theblood vessel. If desired, the vascular patch device 30 may incorporatemalleable support members 24, thereby permitting the surgeon to adjustthe arcuate profile 36 to conform to the radius of curvature of thereceiving blood vessel during implantation.

Referring to FIG. 8, a vascular patch device 30 is shown positionedwithin a blood vessel 14 proximate to an aneurysm 10, wherein the device30 traverses the opening 38 to the aneurysm cavity 18 formed by the neckportion 12. As shown, the expansion of the reactive material 35 resultsin a decrease in the size of the fenestrations 34 formed in the vascularpatch device 30, thereby reducing the amount of blood entering theaneurysm. In an alternate embodiment, the device 30 may include aplurality of attachment devices (not shown) to assist in implanting andsecuring the device within a blood vessel. The attachment devices mayinclude, for example, hooks, barbs, or similar devices manufactured froma plurality of materials, such as platinum, gold, tantalum, titanium,stainless steel, Nitinol, or other suitable material. In an alternateembodiment, the vascular patch device 30 may incorporate alternateattachment mechanisms, including, without limitation, adhesivematerials, mechanical attachment mechanisms, or vacuum attachmentmechanisms. FIG. 9 shows a cross sectional view of a blood vessel 14having the vascular patch device 30 positioned proximate to an aneurysm10. Those skilled in the will appreciate the present embodiment may bemanufactured in a plurality of sizes, thereby enabling usage in variousblood vessels to repair a plurality of aneurysms.

FIGS. 10-12 show an alternate embodiment of an aneurysm treatment deviceuseful in treating aneurysms. As shown in FIG. 10, the aneurysmtreatment device includes a resilient coiled bridge device 40 having asinusoidal body member 42 defining a plurality of openings 44. The bodymember 42 may be formed along an arc 46, thereby aiding in theimplantation of the device while limiting the occlusion of blood vessel.The resilient body member 42 may be compressed along the line 48 toenable delivery and positioning of the coiled bridge device 40 in vivo.Upon placement of the coiled bridge device 40 the resiliency of bodymember 42 exerts an outward pressure along line 50, wherein theresilient body member 42 engages the blood vessel wall (not shown). Inan alternate embodiment, the coiled bridge device 40 may be used toprovide mechanical support to weakened vascular tissue. As shown in FIG.10, the body member 42 is coated with or otherwise disposes a reactivematerial, thereby increasing the resistance to the flow of blood to theaneurysm. FIG. 11 shows an alternate embodiment of the coiled bridgedevice 40 comprising a resilient sinusoidal body member 42 having atleast one reactive section 52 disposed thereon, and defining a pluralityof openings 44. The reactive portions 52 are areas selectively coated orotherwise incorporating a reactive material as defined above. Thepresent embodiment permits the embolization of the aneurysm whilelimiting the occlusion within the blood vessel. FIG. 12 shows a crosssectional view of an aneurysm treatment device positioned within a bloodvessel 14 wherein the at least one reactive section 52 occludes orinhibits blood flow to an aneurysm 10.

FIGS. 13-15 show yet another embodiment of an aneurysm treatment deviceuseful in treating aneurysms formed on weakened vascular tissue. FIGS.13-15 show various implantable expandable intraluminal prostheticdevices commonly referred to as “stents” capable of embolizing orisolating an aneurysm formed on weakened blood vessel tissue. In analternate embodiment, the intraluminal vascular prosthetic devices maybe used to provide mechanical support to weakened vascular tissue. Asshown in FIG. 13, a helical expandable stent 54 comprises a cylindricalbody member 60 disposed between a first end 56 and a second end 58. Thecylindrical body member 60 defines a central lumen 62 co-axially alignedwith the longitudinal axis 64 of the stent 54. The helical expandablestent 54 has a first diameter, D, thereby enabling insertion andpositioning of the device within a blood vessel, and a larger seconddiameter, D′, which is capable of engaging and supporting a blood vesselwall. As shown, a reactive material 66 is selectively applied to theexternal surface of the helical expandable stent 54. FIG. 14 shows analternate embodiment of the helical expandable stent 54, comprising acylindrical body member 60 having a first end 56 and a second end 58.The cylindrical body member 60 further comprises at least one reactivesection 66 disposed thereon, thereby enabling the embolization orisolation of an aneurysm while limiting blood vessel occlusion. FIG. 15shows cross sectional view of the present embodiment positioned within ablood vessel 14, wherein the at least one reactive section 66 occludesor otherwise inhibits blood flow to an aneurysm 10.

In another embodiment, FIGS. 16-18 show various embodiments ofreticulated expandable intraluminal stents. As shown in FIGS. 16 and 17,the reticulated stent 68 comprises a first end 70 and a second end 72,having a cylindrical reticulated body 74 positioned therebewteen. Thecylindrical reticulated body 74, which is comprised of a series ofinterconnected support members 24, defines a flow lumen 76 co-axiallyaligned along the longitudinal axis 78 of the stent 68 having a firstcompacted diameter D, and a second larger diameter D′. As shown in FIGS.16-18, a reactive material may be applied to the external portion of thestent 68. Alternatively, the reactive material may be applied toselected areas or individual support members 24 may be manufactured fromreactive material or otherwise incorporated therein. FIG. 18 shows anembodiment of the reticulated expandable stent 68 positioned within ablood vessel 14, wherein a reactive section 80 is increasing theresistance to the flow of blood to an aneurysm 10.

FIG. 19 show an embodiment of an occlusive bifurcated supports. As shownin FIG. 19, the occlusive bifurcated support 82 comprising a first end84, a second end 86, and a third end 88 and having a cylindrical body 90positioned between the first, second, and third ends, 84, 86, and 88,respectively. The cylindrical body 90 further defines an internal lumen92, which is in communication with the first, second, and third ends,84, 86, and 88, respectively. The occlusive bifurcated support 82 hasfirst diameter D, thereby enabling insertion and positioning of thedevice within a blood vessel, and a larger second diameter D′, which iscapable of engaging a blood vessel wall. As such, the cylindrical body90 may be manufactured from a plurality of interlocking or otherwisejoined support members 24, and may be reticulated. Reactive material 92is incorporated into the cylindrical body 82, thereby occluding theaneurysm 10 formed on the blood vessel 14.

FIGS. 20 and 21 show an embodiment of an occlusive support device. Asshown in FIG. 20, an aneurysm 110 may form on a blood vessel 114 at avascular junction. As discussed previously the aneurysm 110 may comprisea narrow neck portion 112 which is in communication with the bloodvessel 114. The blood vessel 114 includes a first passage 116, a secondpassage 118, and a third passage 120. The occlusive support device 100comprises one or more support members 122 forming a first end 124 and asecond end 126 and defining a lumen 128 therethrough. One or morefenestrations 130 may be defined by the one or more support members 122.When implanted the one or more support members 122 provide support alongline L to the surrounding tissue while permitting blood to flow throughthe fenestrations 130 formed by the support members 122. An end cap maybe secured to the second end 126 of the occlusive support device 100 toinhibit flow into the aneurysm 110. The end cap 132 may be comprisedfrom one or more filamentary elements that can easily be linearized formovement through a catheter. In one embodiment the end cap 132 iscomprised of one of the support members 122 having reactive material 133applied thereto. For example, as shown in FIGS. 20 and 21, the end cap132 comprises a support member 122 formed in a circular shape ofdecreasing diameter 153. The end cap 132 may be substantiallyperpendicular to the longitudinal axis of the support device 100.Alternatively, the end cap 132 may have a convex or concave shape butotherwise positioned to be generally perpendicular to the longitudinalaxis of the support device 100.

In some embodiments, the end cap 132 is designed to bridge the neck 112of aneurysm 110 while minimizing its extension along the length of thesupport device 100 into either the aneurysm 110 or into passages 118 or120 of blood vessel 114. To that end, as shown in FIGS. 20 and 21, theend cap 132 may have a diameter that approximates the size of theaneurysm neck 112 but will also have a relatively short extension alongthe longitudinal axis of the device compared to the length of thesupport device 100 so as to extend minimally into aneurysm 110 or flowpassages 118 or 120. In one embodiment the end cap may have an extensionalong the longitudinal axis of the device that is less than two timesits diameter. In another embodiment the extension of the end cap alongthe longitudinal axis of the device is less than its diameter.

In an alternate embodiment, the end cap 132 may be comprised of aplurality of interwoven support members 122 thereby forming afenestrated end cap. Optionally, the end cap 132 is comprised ofreactive material 133. As such, the end cap 132 may have no reactivematerial thereon, reactive material 133 applied thereto, or manufacturedsolely from one or more reactive materials 133. The diameter of thefilamentary elements of end cap 132 can be made to be thinner thansupport members 122 so that when reactive material 133 is included theoverall diameter of the filamentary elements of end cap 132 can be madeto be less than the overall diameter of the support device. Onceimplanted, the end cap 132 decreases the flow of blood from the firstpassage 116 of the blood vessel into aneurysm 110 formed at the vascularjunction, thereby directing the blood flow into the second and thirdpassages 118, 120. As shown in FIG. 21, a space-occupying material 136may be injected into the aneurysmal space 138 formed in the aneurysm110. For example, a catheter 134 may be advanced though occlusive device100 positioned within a blood vessel 114 and inserted through the endcap 132 into the aneurysmal space 138. Thereafter, a space occupyingmaterial 136 may be injecting or inserted into the aneurysmal space 138from the catheter 134. Exemplary space occupying material 136 include,without limitation, hydrogels, hog hair, microfibrillar collagen,various polymeric agents, material suspensions, metallic or radio-opaquematerials, and other space filling materials. In an alternateembodiment, therapeutic agents may be delivered to the aneurysmal space138 through the catheter 134. Once the space occupying material 136 hasbeen inserted into the aneurysmal space 138 the end cap 132 may be usedto maintain the space occupying material 136 within the aneurysm 110 orto facilitate the formation of a substantially continuous surfacebridging the neck of the aneurysm 110.

FIGS. 22 and 23 show another embodiment of an occlusive support device200. As with the embodiment of FIGS. 20 and 21, device 200 isparticularly applicable for use with aneurysms formed at a vascularjunction. Occlusive support device 200 is particularly useful in caseswhere coils or other embolic materials are being used to fill theaneurysm. Device 200 is structured so that is can be utilized to blockthe neck of the aneurysm to prevent the coils from migrating into theparent artery. As shown in FIG. 22, occlusive support device 200comprises a first end portion or end cap 222 capable of preventing themigration of coils or, in the alternative, of partially occluding theneck 212 of the aneurysm 210. In the illustrated embodiment, end cap 222comprises mesh 224. In alternate embodiments, end portion 222 couldcomprise a screen or plurality of wires or other structure capable ofpreventing migration of coils. The device 200 has an anchoring member226 at a second end portion 228. The mesh 224 a is connected to theanchoring member 228 by elongated members 230. While elongate members230 are shown substantially straight, they may have a number of bends orportions with a serpentine or sinusoidal shape to enhance theflexibility of the device. Further, the elongate members 230 may have acoil-like structure for even greater flexibility. As with the embodimentof FIGS. 20 and 21, the end cap 222 is designed to bridge the neck 212of aneurysm 210 while minimizing its extension along the longitudinalaxis of the device into either the aneurysm 210 or into passages 218 or220 of blood vessel 214. Consequently, as shown in FIG. 23, the end capor mesh 224 may have a diameter that approximates the size of theaneurysm neck 212 but will also have a relatively short extension alongthe longitudinal axis of the device compared to the length of theelongated members 230 so as to extend minimally into aneurysm 210 orflow passages 218 or 220. In one embodiment the end cap may have anextension along the longitudinal axis of the device that is less thantwo times its diameter. In another embodiment the extension of the endcap along the longitudinal axis of the device is less than its diameter.

Mesh 222 may be made from a variety of components such as metallic orfibrous wire, polymer thread or sheet, or cloth. The porosity of mesh224 can be adjusted, depending on the application, from a few strands ofwire to a non-porous plastic barrier. The elongated members 230 can bemade from polymer or metallic wire, thread, or cut from a hypotube ofpolymer of metal. The elongated members 230 may be thin so as tominimize the interruption or blocking of blood flow into other bloodvessels. The elongate members 230 are typically flexible to allow themto bend through tortuous anatomy. The anchoring member 226 may comprisea stent or other ring or sinusoidal member capable of supporting thevessel. The anchoring member 226 may have a variety of cell and strutpatterns and may be either self-expanding or balloon expandable.Anchoring member 226 may be comprised of Nitinol, steel, titanium,chromium cobalt, Elgiloy, platinum or tantalum. Mesh 224 and anchoringmembers 228 may be comprised of polyurethane, PET (Dacron), nylon,polypropylene, Teflon, or other biocompatible polymers.

In one embodiment, device 200 is self-expanding. The self-expandingproperty can be due to elasticity or shape memory. Shape memory devicescan be made from a variety of shape memory materials includingnickel-titanium alloys, commonly known as Nitinol. Elastic devices canbe made using a variety of materials including stainless steels,Elgiloy, titanium, nickel-titanium alloys and cobalt-chrome alloys. Themesh 224 is comprised of fine wires 232 of the same self-expandingmaterial, the wires 232 having a diameter of approximately between0.0005 to 0.005 inches. In one alternative, the mesh wires 232 may belaser cut from a thin sheet of the self-expanding material. The elongatemembers 230 may be made from the same self-expanding material as mesh224 and may comprise wires of the same size as the mesh wires 232.Elongate members 230 could be extensions of mesh wires 232 or, in thealternative, they could be separate members which are attached to mesh224 by, for example, welding, mechanical bonding, or in other ways knownto those of skill in the art. Elongate members 230 may be initiallystraight or shaped into a particular pattern, such as a zig-zag pattern,along their length in order to enhance their flexibility.

Anchoring member 226 may be a self-expanding stent 234 which is formedfrom the same self-expanding material as mesh 224 and elongated members230. The stent 234 may be made from wire, a rolled sheet, cut from ahypotube or made in a fashion known to those of skill in the art instent fabrication. Elongated members 230 may be an extension of thestent pattern or, in the alternative, may be attached to the stent by,for example, welding, mechanical bonding, or in other ways known tothose of skill in the art.

The entire assembly of the device 200 could be collapsed into a sheathor tubular catheter (not shown) having an inner member capable ofcarrying a guide wire. The inner member could also incorporate arestraining element such as a metal holder to grip the stent 234 untilthe sheath is withdrawn using techniques that are known to those ofskill in the art. This would permit the mesh 224 and elongated members230 to be partially deployed and, if necessary, re-sheathed duringplacement of device 200. The distal tip of the delivery sheath could beformed into what is known to those of skill in the art as a shepard'scrook to allow the device to be deployed at a sidewall aneurysm.Radiopaque markers could be placed on either the device 200, thedelivery device, or both, to aid in the visualization and placement ofdevice 200.

In an alternative embodiment, device 200 can utilize a low-porositybarrier material, such as a polyethylene or PTFE sheet to form the mesh224. The elongated members 230 could be formed of the same material. Theelongated members 230 could thus be integral to mesh 224 or, in thealternative, could be attached to the mesh using heat, ultrasound,adhesive bonding, or in other ways known to those of skill in the art.In the alternative, the elongated members 230 could be metallic andcould be attached to mesh 224 by mechanical bonding, by tying theelongated members 230 to mesh 224 using a thread or sutures, or in otherways known to those of skill in the art. Stent 234 could be aself-expanding metal with elongated members 230 attached thereto bymechanical bonding, sewing, welding, or in other ways known to those ofskill in the art. Delivery and deployment of these variations would bethe same or similar as described above,

FIG. 23 shows support device 210 after deployment in a vessel 214.Aneurysm 210 is formed on blood vessel 214 at a vascular junction. Bloodvessel 214 includes a first passage 216, a second passage 218, and athird passage 220. Device 210 is placed so that mesh 224 is proximal tothe neck of aneurysm 210. The mesh 224 blocks the neck of aneurysm 210.Elongated members 230 connect mesh 224 to stent 234, which is deployedin the parent vessel 214 at some distance from aneurysm 210, therebyanchoring mesh 224 in position. Mesh 224 can be sized to approximate thesize of the aneurysm neck, permitting the device to be placed at avascular bifurcation or in complex vascular geometries. The size ofelongated members 230 can be an order of magnitude smaller than thediameter of the branch vessels. Thus, even though elongated members 230might cross the branch vessels they are unlikely to occlude them. Sincethe function of occluding the aneurysm 210 is performed by mesh 224,stent 234 can be relatively short and only needs to have relatively lowradial strength. This greatly enhances the delivery accuracy of thedevice compared to a conventional stent. Furthermore, since the mesh 224is closely sized to the aneurysm neck, its porosity can be adjusted byeither material selection or the addition of expandable coatings orcoverings which could obviate the need for placing coils in theaneurysm.

Device 210 may be deployed in a delivery catheter which is maneuvered tothe aneurysm neck. Mesh 224 may be at the distal end of the catheterwhich is placed proximal to the aneurysm neck and a retaining sheath maybe retracted, deploying the elongated members 226 and then deployinganchoring member 224 in the parent vessel.

In some embodiments, mesh 224 may be made to be sufficiently porous sothat a micro catheter could be positioned at the aneurysm neck todeliver coils or other embolic materials into the aneurysm.Alternatively, a micro catheter may be placed in the aneurysm to delivercoils prior to placement of device 210. In yet another embodiment, mesh224 has a porosity low enough so as to sufficiently occlude the aneurysmfrom blood flow without the need for coils.

In the above embodiments, mesh 224 could be coated with a reactivematerial, such as a hydrogel. In a device where mesh 224 is intended toprovide low-porosity, this variation allows for the device 200 to becollapsed to a smaller size for delivery. Upon delivery of the device,as the hydrogel hydrates, the pores of mesh 224 would become smaller,providing greater occlusion of the aneurysm 210 or greater resistance toflow into aneurysm 210. In any embodiment, the presence of hydrogel atthe neck of aneurysm 210 or 310 can promote a healing response from thebody to help to permanently occlude the aneurysm 210 Or 310.

The devices disclosed in this application can be fabricated with a leasta portion of their external surface having features that promote theadhesion or mechanical interlock of the reactive material. This canimprove the durability of the reactive material. These surface featurescan be created by machining or chemical processing and a reactivematerial can be applied in a variety of ways as described in co-ownedU.S. patent application Ser. No. 10/177,651, the disclosure of which ishereby incorporated by reference, as if fully set forth herein.

For example, The external surface of device 200 may have a topographycharacterized by surface features which deter longitudinal slippage ofthe application of reactive material over the outer surface and/or whichresult in some mechanical engagement or interlock between the reactivematerial and the device 200. In this regard, the outer surface of device200 may have one or more cavities formed therein, at least some of thosecavities having side walls which are disposed at angles of about 75 ormore degrees relative to the longitudinal axis of the device 200 (orrelative to the outer surface of the device 200 immediately adjacent tothose side walls) and wherein at least a portion of the reactivematerial extends into at least some of the cavities so as to deterseparation of the reactive material from the device 200.

In one particular embodiment of the surface modification, grooves orpores are created in the treatment device such that they have at leastone surface that has an angle greater than about seventy five degrees tothe exterior of the treatment device. FIG. 24 shows a substantiallysolid member 242 which has generally rectangular cavities in the natureof slots 246 formed inwardly from the outer surface 247 thereof. Thereactive material 244 is disposed continuously over the outer surface247 of the solid member 242. A longitudinal axis LA is projectablethrough the solid member 242. A wall axis WA is projectable along theside wall 248 of each slot 246. For at least some of the slots 246, thewall axis WA is substantially perpendicular to the longitudinal axis LA,such that angle A will be approximately 90 degrees, as shown in FIG. 24.It will be appreciated that, in some embodiments, the side walls 248 ofat least some slots 246 may be slanted or angled such that the slot 246is wider at its bottom B than at its top T, thereby creating an undercutwhich further mechanically locks or frictionally engages the reactivematerial 244 to the solid member 242. In some embodiments, grooves canbe cut into the external surface of the device in, for example, acircular or helical pattern which is substantially perpendicular to theaxis of the device.

FIGS. 25A-25D show, in step by step fashion, a method for manufacturinga device 262 having non-continuous, discrete deposits of a reactivematerial. In this method, a device 262 having a surface 263 is initiallyprovided as shown in FIG. 25A. A plurality of cavities 266 such as blindbore holes, slots, indentations, depressions, cuts, grooves, etc. areformed in the outer surface 263 of the device 262. This may beaccomplished by any technique known in the art such as mechanicaldrilling, boring, laser etching, cutting, EDM, photochemical etching,etc. As shown in FIG. 25B, wall axes WA projected parallel to at leastportions of the sidewalls 265 of at least some of the cavities 266preferably form an angle A relative to the longitudinal axis LA of thedevice 262 or a longitudinal axis of the outer surface 263 of device 262are preferably greater than 75 degrees and more preferably greater than90 degrees. In some embodiments, as shown in FIG. 25B (alt) thesidewalls 265A of the cavities 266A may be angled or curved such thatthe cavities 266A are wider at their bases B than at their tops T. Thisresults in the formation of an angle A greater than 90 degrees and formsan undercut whereby the later-applied reactive material 264 (FIGS.25C-25D) becomes mechanically or frictionally interlocked or engaged bythe sidewalls 265A of the cavities 266A.

After the cavities 266 or 266A have been formed in the device 262, thereactive material 264 is deposited in the cavities 266 or 266A In someembodiments, such as the specific example shown in FIGS. 25C-25D, thereactive material 264 is a swellable or expandable coating or covering264 which swells or expands after coming in contact with a body fluid BFsuch as blood or other liquid such as saline solution or sterile water.The reactive material 264 may be initially applied over the entire outersurface 266 of the working element 262 and the layer of reactivematerial deposited on the outer surface may then be wiped or scrapedaway, or otherwise removed, leaving discrete deposits of reactivematerial 264 within the cavities 266 such that the upper surface 264 ofeach mass of reactive material 264 is substantially flush with or evenslightly below the level of the outer surface 266.

Thereafter, when the device 262 is immersed in blood or other body fluidBF or when it is immersed in of contacted by a liquid (saline, water,etc.), the deposits of reactive material 264 will expand or swells suchthat the upper surface US of each reactive material deposit 264protrudes above the outer surface 266 of the working element 262.Alternatively, the reactive material may expand in response to changesin its environment, such as changes in physiological pH. In this manner,the expansion of the reactive material creates a non-continuous coatingor covering system which comprises discrete raised knobs, bumps, ridges,etc. of reactive material 264, on the outer surface 266 of the workingelement 262. Such coating or covering 264 may impart lubricity or form aslippery substance which facilitates the desired insertion, positioning,movement and/or withdrawal of the device 262 from the body of a patient.

Referring again to FIG. 23, in a particular embodiment which utilizes areactive material applied to mesh 222, the reactive material may haveoperations applied to it after it has been applied to remove materialsin certain areas. For example, the reactive material may be applied tothe wire mesh 224 in a substantially uniform thickness and thereaftermachined to selectively remove material so that the pores of the mesh224 are substantially filled with the reactive material once it hydrateswithout adding to the thickness of the mesh itself.

FIGS. 26 and 27 show an embodiment of an intra-aneurysmal neck bridgestructure. As shown, the intra-aneurysmal neck bridge structure 150comprises device body 152 in communication with at least two engagementmembers 154A and 154B cooperatively forming a device joint 156. In oneembodiment, the device joint 156 sealably isolates the aneurysm from theflow of blood through the blood vessel. The engagement members 154A-Bare formed to approximate the radius of curvature of the aneurysmthereby providing an interface between the device and the aneurysm.Reactive portions 158A-B are positioned on the engagement members154A-B, respectively. As shown in FIG. 27, a reactive or occlusivematerial 160 may be inserted into the aneurysm 162 prior to or afterapplying the intra-aneurysmal neck bridge structure 150. Such reactiveor occlusive materials 160 may include, for example, a plurality ofmaterials such as hydrogels, hog hair, microfibrillar collagen, variouspolymeric agents, material suspensions, metallic or radio-opaquematerials, and other space filling materials.

The present application further discloses methods of treating vascularaneurysms. In the one embodiment, a method of percutaneously insertingan aneurysmal treatment device into an aneurysm is disclosed andincludes percutaneously inserting am aneurysmal treatment device into ablood vessel, advancing the treatment device to a location proximate toa vascular aneurysm, and applying the device to the aneurysm orsurrounding tissue without substantially restricting blood flow throughthe blood vessel. The aneurysm treatment devices disclosed in thepresent application may be delivered to a situs in vivo in a pluralityof manners, including, for example, on guidewires, balloon catheters orthrough micro-catheters. FIG. 28 shows an exemplary embodiment 170 of ananeurysm treatment device being applied to an aneurysm 172 using aballoon micro-catheter 174.

In practice, the surgeon positions an aneurysm treatment device, forexample, an expandable reticulated stent 170 on a delivery device, forexample, a micro-balloon catheter 174. Thereafter, a first incision ismade proximate a blood vessel and a guidewire 176 is inserted therein.Commonly, the guidewire will enter the circulatory system through thefemoral artery, the femoral vein, the jugular vein, the carotid artery,or a similar blood vessel. The guidewire 176 may then be directedthrough the circulatory system to a location proximate to the aneurysm172 and, thereafter, made to exit the body through a remote exit point.The delivery device 174 and stent 170 may then be advanced along theguidewire 176 and positioned proximate to the aneurysm 172. Typically,visualization methods, such as fluoroscopy, ultrasound visualization, orechogenic location are utilized to precisely position the deliverydevice near or within the aneurysm 172. Once positioned, themicro-balloon 174 is inflated and the expandable reticulated stent 170is applied to the tissue. The portion of the expandable reticulatedstent 170 disposing the reactive material 178 is positioned proximate tothe aneurysm. Thereafter, the delivery device 174 and guidewire 176 areremoved from the body. The activation of the reactive material 178selectively applied to the stent 170 increases the resistance to theflow of blood to the aneurysm 172. The activation process may resultfrom a plurality of occurrences, including, for example, the presence ofa physiological pH for an extended period, the presence of an enzyme orother material within the blood, electromagnetic-activation resultingfrom the introduction of a pre-determined wavelength of electromagneticenergy. The procedure above discloses one such activation method,however, other activation methods known in the art are contemplated.

Optionally, the method of treating an aneurysm may include an embolicmaterial or one or more devices which may be inserted either prior to orafter the deployment of the treatment device.

In closing it is understood that the embodiments of the aneurysmtreatment device disclosed herein are illustrative of the principles ofthe invention. Other modifications may be employed which are within thescope of the invention. Accordingly, the present invention is notlimited to that precisely as shown and described in the presentinvention.

1. An apparatus for treating vascular aneurysms, comprising: an occlusive support device comprising one or more support members forming a first end portion and a second end portion and defining a lumen therethrough; and an end cap member at said first end portion of said occlusive support device; wherein said end cap member has openings and said end cap member comprises a reactive material that is configured to hydrate upon delivery of the device and to reduce the size of said openings; and an anchoring member at said second end portion.
 2. The apparatus of claim 1 wherein said end cap member comprises at least one of said one or more support members.
 3. The apparatus of claim 1 wherein said end cap member comprises a support member formed in a circular shape of decreasing diameter.
 4. The apparatus of claim 1 wherein said end cap member comprises a plurality of interwoven support members forming a fenestrated end cap.
 5. The apparatus of claim 1 wherein said reactive material is applied to said end cap member.
 6. The apparatus of claim 1 wherein said end cap member comprises a porous material.
 7. The apparatus of claim 1, wherein said end cap is capable of increasing the resistance of blood flow therethrough.
 8. The apparatus of claim 1 wherein said end cap member comprises one or more filamentary elements.
 9. The apparatus of claim 8 wherein said filamentary elements are arranged to form an end cap member selected from the group consisting of a coil, a weave, a braid, a mesh, a screen, and a cable.
 10. The apparatus of claim 1 wherein said reactive material is a hydrogel.
 11. The apparatus of claim 1 wherein said reactive material in configured to expand in response to changes in physiological pH.
 12. The apparatus of claim 1 wherein said end cap member comprises a mesh member comprised of a plurality of wires.
 13. The apparatus of claim 12 wherein said mesh member is comprised of fine, self-expanding wires.
 14. The apparatus of claim 12 wherein said mesh member is a low porosity mesh member.
 15. The apparatus of claim 14 wherein said low porosity member is a nonporous barrier.
 16. The apparatus of claim 1 wherein said end cap has an extension along said longitudinal axis of said device that is less than said end cap diameter.
 17. The apparatus of claim 1 wherein said end cap has an extension along said longitudinal axis of said device that is less than two times said end cap diameter.
 18. The apparatus of claim 1, wherein said support device is substantially cylindrical and said support device comprises one or more support members along said longitudinal axis and defining fenestrations through said support device.
 19. The apparatus of claim 18 wherein said end cap member comprises a plurality of said one or more support members interwoven together.
 20. The apparatus of claim 1 wherein said anchoring member is a stent.
 21. The apparatus of claim 20 wherein said stent is comprised of support members defining fenestrations through said support device.
 22. The apparatus of claim 1 further comprising a plurality of elongated members along said longitudinal axis and connecting said end cap member to said anchoring member.
 23. The apparatus of claim 22 wherein said end cap member is comprised of self-expanding end cap member wires and said elongated members comprise the same selfexpanding material as said end cap member and said elongated members comprise wires of the same size as said end cap member wires.
 24. The apparatus of claim 23 wherein said elongated members are extensions of said end cap member wires.
 25. The apparatus of claim 23 wherein said elongated members are attached to said end cap member.
 26. The apparatus of claim 23 wherein said anchoring member is comprised of the same self-expanding material as said end cap member and said elongated members.
 27. The apparatus of claim 23 wherein said elongated members are an extension of said anchoring member.
 28. An apparatus for treating vascular aneurysms, comprising: an occlusive support device comprising a longitudinal axis having first end portion and a second end portion; an end cap member at said first end portion of said occlusive support device, wherein said end cap member has an end cap diameter and said end cap is generally perpendicular to said longitudinal axis of said support device, wherein said end cap has an extension along said longitudinal axis of said device that is less than two times said end cap diameter and wherein said end cap member has openings and said end cap member comprises a reactive material that is configured to hydrate upon delivery of the device and to reduce the size of said openings; and an anchoring member at said second end portion.
 29. The apparatus of claim 28 wherein said reactive material in configured to expand in response to changes in physiological pH.
 30. An apparatus for treating vascular aneurysms, comprising: an occlusive support device comprising one or more support members forming a first end portion and a second end portion and defining a lumen therethrough; and a mesh end cap member at said first end portion of said occlusive support device, said mesh end cap member comprised of at least one of said one or more support members; wherein said end cap member has openings and said end cap member comprises a reactive material that is configured to hydrate upon delivery of the device and to reduce the size of said openings; and an anchoring member at said second end portion.
 31. The apparatus of claim 30 wherein said reactive material in configured to expand in response to changes in physiological pH. 32-38. (canceled) 